License Agreement

Software License Agreement

PLEASE READ THIS SOFTWARE LICENSE AGREEMENT (“LICENSE”) CAREFULLY BEFORE USING THE SOFTWARE OF ARES TRADING SA, ZONE INDUSTRIELLE DE L’OURIETTAZ, 1170 AUBONNE, SWITZERLAND (“ATSA”). BY USING THIS SOFTWARE YOU ARE AGREEING TO BE BOUND BY THE TERMS OF THIS LICENSE. IF YOU DO NOT AGREE TO THE TERMS OF THIS LICENSE, DO NOT USE THIS SOFTWARE AND/OR CLICK THE BOX TO DECLINE USE.

User and ATSA agree as follows:

1. Definitions.

The following terms shall have the following meaning under this Agreement:

“Affliliates”: any business entity, which controls, is controlled by or is under common control of ATSA. Control shall mean direct or indirect ownership of more than 50% of voting interest or possession otherwise, directly or indirectly, of power to vote on or otherwise direct affairs of entity. In this Agreement any reference to ATSA shall include Affiliates except where otherwise specified. For the avoidance of doubt, Merck Serono SA, Switzerland, shall be an Affiliate of ATSA for the purpose of this Agreement.

“Documentation”: the operating specifications set forth in the Software user manual as amended by ATSA from time to time.

“Hardware”: the computer hardware or software products which User has procured under its own sole and exclusive responsibility in order to operate the Software.

“License”: the non-exclusive non-transferable right to use the Software subject to the terms and conditions of this Agreement.

“Maintenance Services”: the provision of (i) telephone or email support (ii) Service Releases and/or (iii) Software Updates as determined by ATSA in its sole and absolute discretion.

“Software Updates”: new or later versions of the Software which typically include combined Service Releases and minor product enhancements and are designated by an integer change to the right of the decimal point in the product number and which are made generally available by ATSA.

“Service Releases”: bug fixes, patches and/or workarounds for the correction of errors which are made available by ATSA in its sole and absolute discretion.

“Software”: the Easypod Connect Software (including its components modules Dashboard, ECKO and/or ECOS), including any Software Updates and Service Releases, which is standalone software intended and provided solely for the limited purpose of storage and administration of patient data by a Health Care Professional user for general information. The Software does not drive or influence any existing medical device.

“User”: the Health Care Professional using the Software who shall be a medical doctor duly authorised to practice in the country of use. This Software is intended only for Users resident in the authorised countries listed in the Software.

2. Availability.

ATSA reserves the right, in its sole and absolute discretion, to refuse, offer, grant, interrupt, suspend or withdraw access to the Software, Software Updates, Services Releases or Maintenance Services for any potential User at any time without notice or liability, including without limitation for any loss of access to or use of data previously stored by the User.

3. Grant of License.

Upon acceptance by User of the terms and conditions of this Agreement, ATSA shall grant to User a license to use the Software in object code form only. The License shall remain in effect perpetually unless terminated earlier in accordance with this Agreement. The downloading and use of the Software by User under this License is subject to the continued acceptance by User of all terms and conditions governing such Software as may be amended from time to time by ATSA.

4. Permitted Uses and Restrictions.

4.1 User may only use the Software in accordance with its purpose as defined and contemplated under this Agreement in furtherance of its internal operations.

The Software is not developed, intended or licensed for use (a) in any inherently dangerous applications, (b) to drive and influence use of a medical device, (c) for use by patients or other persons besides the User who shall be a Health Care Professional or (d) for use by any person who is not a resident in/of an authorized country listed in the Software.

The Software, including any calculations, rates, visual or other presentation of data it contains, is not of clinical predictive value and is provided for general informational purposes only. In particular any dose calculation or any dose adjustment shall be made by User according to his/her own clinical assessment of the individual patient without placing reliance on the Software. User has full and final responsibility for the analysis, review and assessment of the data shown.

4.2 User may install, copy or transmit the Software in whole or in part only as necessary to use the Software. User is responsible for ascertaining, seeking and obtaining any and all necessary prior consents and authorisations User may require before Software is installed and during the period of use. The Software is protected by the copyright laws of Switzerland and international treaties. In conjunction with the License granted hereunder, User may make a reasonable number of backup copies of the Software for disaster recovery and archival purposes. User may not assign, rent, sublicense, “timeshare,” or transfer the Software. User may not publish the results of any benchmark tests on the Software. Any use of the Software other than as expressly permitted by the License granted hereunder is prohibited.

4.3 User may, from time to time, change the location of initial installation, provided that on transferring the Software to a different country, User takes full payment responsibility for any applicable taxes, tariffs or duties that may be payable on such transfer. To ensure compliance with the terms of this Agreement, ATSA reserves the right to audit User’s use of the Software time and User consents to and shall give ATSA such access that it may reasonably require to perform such audit. To the extent the Software includes a sublicense of third-party software, User may not use such third-party software for any purpose other than in the operation of the Software. In the event that User uses such third-party software for any purpose other than as permitted by these terms and conditions, User shall hold harmless and indemnify ATSA from and against any claims or damages asserted by any third-party arising out of such improper use, including the cost of defence.

4.4 User shall at all times comply with all applicable federal, state and local laws and regulations when Software is used. In particular, if Software and Maintenance Services are used in clinical applications, User shall at all times comply with all applicable rules and regulations of the competent public authorities and agencies with respect to application of, as the case may be and without limitation, Good Practices in general (“GXP”), Good Clinical Practices (“GCP”), Good Laboratory Practices (“GLP”) or Good Manufacturing Practices (“GMP”).

5. Ownership and Intellectual Property Rights.

5.1 User acknowledges that title and full ownership rights to the Software, including Software Updates, and of all copyright, trade secret, patent, trademark and other intellectual or industrial property rights therein remain with ATSA and with the manufacturers of any third-party software included with the Software (except for any third party owned content which has been identified as such). Physical copies of the Software, in whatever form provided by ATSA, shall remain the property of ATSA, and such copies shall be deemed to be on loan to User during the term of the License.

5.2 User acknowledges that the ideas and the expressions thereof contained in the Software are both proprietary information and trade secrets of ATSA and any third-party manufacturers. User shall not cause or permit the (i) modification, adaptation, translation, decompilation, disassembly, reverse engineering or other reduction of the Software to a human-perceivable form; (ii) the disclosure, copying, display, loan, publication, transfer of possession (whether by sale, exchange, gift, operation of law or otherwise) or other dissemination of the Software, in whole or in part, to any third party (excluding third parties who are licensed users); nor (iii) the creation of derivative works of the Software without the prior written consent of ATSA. User shall take all reasonable steps to safeguard the Software and to ensure that no persons having access to the Software shall take any action in violation of this Agreement. User shall take further steps as may reasonably be requested by ATSA to prevent or remedy any such violation.

5.3 User shall not alter or remove any copyright, trade secret, patent, trademark, proprietary and/or other legal notices contained on or in copies of the Software. User shall reproduce all such notices on or in all copies of the Software permitted under this Agreement. User shall use its best efforts to safeguard and protect ATSA’s copyright, trade secret, patent, trademark and other intellectual or industrial property rights, including taking such steps as User takes to protect its own copyright, trade secret, patent, trademark and other intellectual or industrial property rights.

6. Maintenance Services, Software Updates and Service Releases.

ATSA may at its option provide some limited Maintenance Services, Software Updates and Service Releases but shall have no obligation to do so. The content, extent and availability of such Maintenance Services, Software Updates and Service Releases shall be defined by ATSA in its sole and absolute discretion in accordance with Article 2.

7. Disclaimer of Warranties.

THE SOFTWARE IS PROVIDED TO USER BY ATSA AND ANY THIRD PARTIES RETAINED BY ATSA “AS IS” WITHOUT WARRANTY OF ANY KIND, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, INCLUDING FITNESS FOR USE IN CLINICAL DIAGNOSTIC PROCEDURES OR FOR INVESTIGATIONAL USE WITH OR WITHOUT CONFIRMATION OF DIAGNOSIS BY ANOTHER MEDICALLY ESTABLISHED DIAGNOSTIC PRODUCT OR PROCEDURE, OR NONINFRINGEMENT, AND ANY WARRANTIES ARISING OUT OF COURSE OF DEALING OR COURSE OF PERFORMANCE.

USER EXPRESSLY ACKNOWLEDGES AND AGREES THAT USER IS SOLELY RESPONSIBLE FOR USE OF THE SOFTWARE IN GENERAL, IN CLINICAL DIAGNOSTIC PROCEDURES OR FOR INVESTIGATIONAL USE WITH OR WITHOUT CONFIRMATION OF DIAGNOSIS BY ANOTHER MEDICALLY ESTABLISHED DIAGNOSTIC PRODUCT OR PROCEDURE.

USER ASSUMES ENTIRE RISK AS TO THE INSTALLATION, ACCURACY AND USE OF THE SOFTWARE, INCLUDING OBTENTION OF ANY AUTHORISATIONS AND CONSENTS REQUIRED BY USER FOR INSTALLATION AND USE OF THE SOFTWARE. IN PARTICULAR ATSA DOES NOT WARRANT THAT THE INSTALLATION AND OPERATION OF THE SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE OR THAT DEFECTS IN SOFTWARE WILL BE CORRECTED.

USER SHALL ASSUME THE ENTIRE COST OF ALL NECESSARY EQUIPMENT (HARDWARE, THIRD PARTY SOFTWARE, INTERNET ACCESS, ETC.) FOR THE INSTALLATION AND USE OF THE SOFTWARE, INCLUDING ANY SERVICING OR REPAIR ARISING OUT OF OR IN CONNECTION WITH SUCH INSTALLATION OR USE.

NO EMPLOYEE OR AGENT OF ATSA IS AUTHORIZED TO GIVE REPRESENTATIONS, WARRANTIES OR COVENANTS GREATER OR DIFFERENT THAN THOSE CONTAINED IN THIS AGREEMENT.

8. Indemnification.

8.1 ATSA SHALL NOT INDEMNIFY USER IN ANY WAY.

8.2 User agrees to indemnify and hold ATSA and any third-party manufacturer harmless from any claims for losses, costs, damages, or liability arising out of or in connection with the Software to the extent any such claim is based upon:

  1. (a) Use of the Software in combination with equipment or software not supplied hereunder where the alleged infringement would not exist but for such combination;
  2. (b) Use of the Software in an application or environment for which it was not designed or not contemplated under this Agreement, in particular as set forth in Article 4;
  3. (c) Use of other than a current release of the Software provided to User by ATSA;
  4. (d) Unauthorized modifications of the Software by anyone other than ATSA; and/or
  5. (e) Any claims of infringement of any patent, copyright, trade secret, trademark or other proprietary right in which User has an interest.

9. Confidentiality and Data Privacy.

9.1 User shall require that the (a) Software, whether installed on the User’s equipment or not, (b) the Documentation and (c) all data, including any sensitive personal health data of a patient, entered, created, generated or recorded by User in Software, be kept on the User’s premises securely in a manner so as to reasonably preclude unauthorized persons from having access thereto. User shall permit such access only as necessary for use, operation and maintenance of the Software, including without limitation by ATSA as set forth in Article 11.

9.2 At the request of ATSA, User shall use reasonable efforts to assist ATSA in identifying any use, copying, or disclosure of any portion of the Software by any present or former User in any manner that is contrary to the provisions of this Agreement, so long as ATSA shall have provided User with information reasonably justifying the conclusion of ATSA that such contrary usage may have occurred.

9.3 The restrictions set forth in this Section respecting confidentiality of the Software shall not apply to any portion of the Software that (1) is in or becomes part of the public domain or (2) is required to be disclosed by User pursuant to any order or directive of a court or governmental agency of competent jurisdiction, in the event that User has furnished ATSA notice of such directive or order prior to disclosure.

9.4 All data, including any sensitive personal health data of a patient, entered, created, generated or recorded by User in Software remains under the sole and exclusive responsibility of User who shall take full responsibility (a)for keeping this data confidential at all times in accordance with applicable laws, in particular health data privacy regulations, and (b) obtaining all required consents from patients and any legally entitled persons prior to entry of such data into the software, maintaining such consent during use, granting access to review data and correcting or deleting data in accordance with patients’ requests. In particular, in the event User seeks technical support in connection with Software, User shall (a) ensure that all data is anonymised to ensure patient data is not identifiable before transmission to a third party, (b) obtain all required consents from patient and any other legally entitled persons and (c) make all arrangements User deems fit to comply with all data privacy and any other confidentiality duties under applicable laws prior to performance of such technical support services by ATSA, its third party providers or any other third party.

10. Consent to Use and Storage of Data; Access, Correction and Deletion of Data about User.

User agrees that ATSA and its third party providers may collect and use personal information provided by User, including but not limited to User’s email address, name and place of work; technical information about User’s computer, software and email address that is gathered during use; any other information gathered about the User during use of this Software or during an audit conducted under this Agreement. This information shall be used to facilitate the provision of Software Updates, Service Releases, Maintenance Services or for any other purpose connected with the performance of this Agreement by ATSA.

In addition, User agrees that ATSA and its Affiliates, its employees and third party providers shall have access to statistical data, including biostatistics, generated by the Software based on the data entered by User into the Software provided such access is granted as part of a study and all necessary formalities required under the study protocol are complied with.

The operation of the Software may require that data entered by User into Software be stored elsewhere than on the User’s computer at a location determined by ATSA in its sole and absolute discretion. This location may be outside the country of User requiring a cross-border transfer of data. This location may be under the control of ATSA or a third party which has been contracted by ATSA. In the event this data includes personal data, the data shall be anonymised and encrypted by the Software at the latest upon entry into the database to ensure the name of the patient cannot be identified. User agrees and consents to ATSA maintaining and operating the Software, including storage of data, as described in this Agreement.

In accordance with data protection law, User shall have the right to request access to the personal information collected about the User by ATSA and its third party providers under this Agreement. The User shall have the right to require ATSA and its third party providers correct any inaccuracies free of charge or to request deletion of his/her personal information. In the event of a deletion, ATSA and its third party providers shall keep a record of User’s request for deletion and the date upon which this deletion occurred. Any such request by User shall be made in writing by User sending a letter to ATSA, Data Protection Office at the address indicated at the head of this Agreement.

11. Limitation of Liability.

ATSA AND ANY THIRD PARY RETAINED BY ATSA SHALL HAVE NO LIABILITY WITH RESPECT TO THE SOFTWARE, INCLUDING (BUT NOT LIMITED TO) ANY LIABILITY FOR BREACH OF WARRANTY, OR FOR INFRINGEMENT OR ALLEGED INFRINGEMENT OF PATENT, COPYRIGHTS, TRADEMARKS, TRADE SECRETS AND OTHER INTELLECTUAL OR PROPRIETARY RIGHTS BY THE SOFTWARE OR HARDWARE, OR THEIR USE. IN NO EVENT SHALL ATSA BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, BUT NOT LIMITED TO, LOSS OF PROFITS, LOSS OR INACCURACY OF DATA OR LOSS OF USE DAMAGES, EVEN IF ATSA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

12. Payment.

12.1 No fee shall be due by User to ATSA for use of the Software in accordance with this Agreement.

12.2 User shall bear all fees, costs and expenses incurred in connection with this Agreement or its performance. Any tax, duty, custom or other fee of any nature imposed upon the transactions under this Agreement by any federal, state or local governmental authority shall be paid by User. In the event ATSA is required to prepay any such tax or fee, User shall reimburse ATSA amounts equal to any taxes paid or payable by ATSA, however designated or levied on Software, including without limitation, sales, use, transfer and other taxes and duties imposed by any federal, state, municipal or other governmental authority, and any taxes or amounts in lieu thereof, exclusive, however, of taxes based on the net income of ATSA. User agrees to pay, or provide an appropriate exemption certificate for, all governmental taxes, fees and duties (exclusive of taxes based on ATSA net income), including but not limited to, sales, use, value added, transfer or other taxes.

13. Termination.

This License is effective until terminated. This License will terminate automatically and without notice in the event (a) User breaches any terms and conditions of this Agreement, (b) User ceases to have the status of a Healthcare Professional or (c) ATSA decides in its sole and absolute discretion to withdraw the Software whether from a particular User, a particular territory and/or entirely from the market. Upon termination of this Agreement, User shall pay all sums owed and return all copies of the Software to ATSA. At the request of ATSA, User shall certify in writing that all copies including archival and disaster recovery copies thereof have been destroyed and/or deleted from User’s computer libraries or storage facilities and are no longer in use.

14. Enforcement.

Because User’s breach of any of its obligations under this License may irreparably harm ATSA and may substantially diminish the value of the proprietary rights in the Software, User agrees that if it breaches any of said obligations, ATSA may, without limiting its other rights or remedies, be entitled to seek equitable relief (including, but not limited to, injunctive relief) to enforce User’s obligations and to protect the proprietary rights of ATSA.

15. Assignment.

User may not delegate any of its duties or assign, transfer or sublicense any of its rights or obligations under this Agreement without ATSA prior written consent.

16. Severability.

It is intended that this Agreement shall not violate any applicable law and the unenforceability or invalidity of any provision shall not affect the force and validity of the remaining provisions and such invalid provisions shall be deemed severed from this Agreement and, if permissible, be replaced with terms which as closely as possible approximate the interest and economic intent of such invalid provisions as mutually agreed by the parties.

17. Entire Agreement and Governing Language.

This Agreement, as amended from time to time by ATSA, constitutes the complete and exclusive statement of the agreement between User and ATSA with respect to the Software. No waiver, consent, modification, amendment or change of the terms of this Agreement shall be binding on ATSA unless in writing and signed by ATSA’s authorised representatives. The English version of this Agreement shall govern and prevail over any translations.

18. Survival.

Sections 2, 4, 5, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 and 19 shall survive termination of this Agreement.

19. Governing Law and Jurisdiction.

This Agreement shall be governed by and construed in accordance with the laws of Switzerland without reference to conflict of laws principles and specifically excluding the U.N. Convention for the International Sale of Goods. Any and all disputes or controversies arising in connection with this Agreement shall be subject to the exclusive jurisdiction of the courts of Geneva, Switzerland, to whose jurisdiction Ares Trading S.A. and User each hereby irrevocably consents and submits.

Ares Trading SA

Zone Industrielle de l’Ouriettaz

1170 Aubonne, Switzerland